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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 021528


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NDA 021528 describes ACULAR LS, which is a drug marketed by Abbvie and is included in one NDA. It is available from three suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ACULAR LS profile page.

The generic ingredient in ACULAR LS is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 021528
Tradename:ACULAR LS
Applicant:Abbvie
Ingredient:ketorolac tromethamine
Patents:8
Pharmacology for NDA: 021528
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 021528
Suppliers and Packaging for NDA: 021528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528 NDA Allergan, Inc. 0023-9277 0023-9277-05 1 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPER
ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-3550 50090-3550-0 1 BOTTLE, DROPPER in 1 CARTON (50090-3550-0) / 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.4%
Approval Date:May 30, 2003TE:ATRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Nov 24, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Nov 28, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Sign UpPatent Expiration:Nov 28, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021528

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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